Based on 2010 data published by the CDC (2011) [Centers for Disease Control and Prevention (CDC) National Diabetes Fact Sheet: 2011: “National estimates and general information on diabetes and prediabetes in the United States”, Atlanta, Ga. USA.] (Reference 1). Diabetes affects 25.8 million people or 8.3% of the United States population. 18.8 million are diagnosed diabetics and 7.0 million people are undiagnosed. Applying the percentages of diabetics in the United States derived from various large population studies, it is estimated that 79 million American adults 20 years old and older are pre-diabetics.
Of the diabetic population in the US 12% use only insulin to regulate their blood sugar levels and 14% use a combination of insulin and oral medication (Reference 1). In essence, 26% of the diabetic population of 18.8 million will use a select variety and combination of injectable insulin supplied in glass ampules containing 10 cc. preparations namely: Lantus®; Novolog®; Humalog®; Novolin®; and Humulin® to mention a few. Each of these preparations is shipped or sold to the patient in a very small weak thin cardboard box. The potential for the box to fall apart, become contaminated due to multiple daily use and storage and for the glass ampule to fall and break is very real. Each broken or contaminated ampule represents a loss of $150.00 or more
The invention helps not only US diabetics that are on insulin but also the hundreds of millions around the world who face certain contamination, infection and breakage from daily withdrawal and injection of insulin. The inventor personally used the device to store the two different insulin preparations he uses to medicate himself without any incident of contamination, infection or breakage of any insulin ampule over a reasonable test period.
There are a variety of containers on the market suited for pharmaceutical prescription medicines. Moreover, the expanded use of insulin for treatment of diabetes is currently more prevalent than in the past due to the production of more pure insulin preparations. Insulin can be administered by insulin pumps, insulin pens and most economically by mechanical withdrawal of hypodermic insulin solution from glass ampules. The current supply of 10 cc. of insulin solution in ampules is the least expensive of the various preparations. The glass ampules are supplied in small cardboard boxes that provide inadequate protection to the medication once the box is opened for use. There is often a deterioration of the original cardboard box due to multiple daily handling for insulin withdrawal. Furthermore, handling of the insulin containing ampule frequently increases the chance of breakage and loss of the insulin content. Also the multiple daily handling would increase the likelihood of contaminating the outside of the ampule and the hypodermic injection site leading to painful infections at such sites. The insulin preparations supplied in ampules can be kept at room temperature for up to 30 days, but the product is not marketed in a container that can safely last through such a prolonged use.
Various attempts have been made to address the containment and transport of pharmaceuticals and in particular insulin ampules. Zou Yuanyi, et al. [Zou Yuanyi, et al.; Univ Shanghai Electric Power: “portable insulin heat-preserving container with refrigerating function”. Shanghai University of Electric Power, CN202687120 (U)-2013-01-23 (September 2013).] (Reference 2) relates to the complicated transport of insulin in a container that is heat-preserving and with refrigerated function. A similar approach for a diabetic traveling case is taught in [Emil G. Ehman: “Diabetic traveling case”. Publication Number: U.S. Pat. No. 4,429,793A and Published as DE3316361A1, DE8313241U1 (May 1982).] (Reference 3) with use of a refrigerant to keep the insulin from spoiling. A diabetic two-fold medical case [Edna Ford: “Diabetic two-fold medical case”. U.S. Pat. No. 8,550,251B1 (October 2013).] (Reference 4) is documented but the problem with these devices is that they are large, heavy and cumbersome for multiple daily use for the average diabetic patient to appreciate. They also do not address the breakage and contamination of the ampule by direct handling.
A similar large and cumbersome container as reported by Edna Ford (Reference 4) was declared by Kahilainen [Hannu Kahilainen: “Patient's container of medical equipment for use at home”, [FI/FI] Ritakuja 6, Kangasala (FI). International Publication Number WO1995009579A1 (April 1995).] (Reference 5) as an invention of a container of medical equipment for use by diabetic patients. The patient's main concern is to safeguard the insulin ampule from contamination and prevent infection and breakage throughout the multiple uses per day for an average of thirty day life span of each ampule.
Other declarations dealing with the art include Koslovskyh [H Koslovsky: “Medicant withdrawal unit”. U.S. Pat. No. 3,762,673 (A). (February 1973).] (Reference 6) who relates to a medical unit for withdrawing insulin with one hand, while Fuerther Guenter [Fuerther Guenter: “Diabetic set”. U.S. Pat. No. 4,446,970 (A) (August 1984).] (Reference 7) presents a diabetic set with accessories for the “hygienic” withdrawal and injection of insulin. Xiaofeng Zhang, et al. [Xiaofeng Zhang, et al.: “Insulin storage containers”. CN201990069 (U) (September 2011).] (Reference 8) describe an insulin storage container composed of a box and box cover with magnets and iron plates to seal and facilitate access to the insulin. Jentis Rebbecca et al. [Jentis, et al.: “Improvements in insulin preserving travel kit for diabetics”. GB1017324 (A) (January 1966).] (Reference 9) and Steffen Lay, et al. [Lay, et al.: “A medical apparatus for use by a patient for medical self treatment of diabetes”. WO1999059657A1 (November 1999).] (Reference 10) reported on a complicated portable container for carrying insulin during travel.
All the pertinent cited literature demonstrated costly and cumbersome devices suited for handling earlier insulin preparations when insulin was extracted from animal pancreatic tissues. The modern day insulin preparations are pure and prepared from genetically engineered cultures. Such new preparations can remain at room temperatures for up to 30 days of use.